Cancer biomarkers are molecular or genetic moieties (e.g., cells,
proteins/peptides, genetic mutations, gene products, enzymes, or hormones) that
not only are readily identifiable, but easily quantified in the lab setting.
They function primarily to identify or correlate significantly with the severity
or occurrence of a certain disease state. The rise in number of oncogenic
biomarkers over the last number of years has massive potential in the healthcare
industry and serves to propel both the personalized medicine and companion
diagnostic markets.

One of the most import aspects of biomarkers is their use to diagnose and assess
the progress of disease states in patients. As quantitative markers, these
agents also offer the ability to monitor response to certain drug treatments and
so are important in the area of personalized medicine.

Individualized, targeted or personalized medicine aims to increase the efficacy
of therapeutics via genetic testing and companion diagnostics. Personalized
therapeutics and associated companion diagnostics will be more specific and
effective thereby giving pharma/biotech companies a significant advantage to
recuperate R&D costs. Personalized medicine will reduce the frequency of adverse
drug reactions and therefore have a dramatic impact on health economics.
Developmental and diagnostic companies will benefit from lower discovery and
commercialization costs and more specific market subtypes.

This report describes the current technologies that are propelling the cancer
biomarker and companion diagnostic market. It examines the current genetic
diagnostic tests and companion diagnostic assays that are in use by the medical
and pharmaceutical industry today. Current developments in personalized medicine
and the pharmacogenomics revolution are discussed. The emerging trends that
appear in the global market and the most developed market (US) are elucidated
and analysed. This study reveals market figures of the overall biomarker market
and the cancer biomarker space (2013-2018). Forecast projections and future
growth rates are provided to give the reader a forthcoming perspective of this
growing industry.

The study also provides a comprehensive financial, business strategy and product
review of key players in the cancer biomarker industry. Strategic drivers and
restraints of this market are revealed and market opportunities and challenges
are identified.

In summary, the cancer biomarker and associated companion diagnostic market have
huge opportunities for growth. This industry will revolutionize the healthcare
system and will improve therapeutic effectiveness and reduce the severity of
adverse effects. It has enormous potential for investment and the emergence of
genetic-based in vitro diagnostics.

Table 4.1: Current General Classes of Biomarker Assay as Defined by the American
Association of Pharmaceutical Scientists 73
Table 4.2: Comparison of Validative Properties of Different Bioassay Classes 73

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